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Case 3:19cv03361JSC Document 1 Filed 06/13/19-Page 1 of 161 2 3 4 5Craig M. Murphy, Esq. California Bar No. 314526 Craig nvpilaw.com MURPHY & MURPHY LAW OFFICES 4482 Market Street, Ste 407 Ventura,
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Development and validation refer to the process of creating and verifying a system or product to ensure it meets specified requirements and performs as intended.
Entities involved in research, product development, and regulatory compliance in various industries such as pharmaceuticals, biotechnology, and manufacturing are typically required to file development and validation.
Filling out development and validation documents involves providing detailed descriptions of the development process, validation protocols, results, and compliance with applicable regulations and standards.
The purpose of development and validation is to demonstrate that a system, process, or product functions correctly and meets all regulatory requirements, thereby ensuring safety and efficacy.
Information that must be reported includes objectives of development, methodologies, testing results, compliance documentation, and any deviations or issues encountered.
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